BioMimetic bone graft wins panel support

The US Food and Drug Administration's (FDA) Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee has voted in support of BioMimetic Therapeutics' Augment Bone Graft for use as an alternative to autograft in hindfoot and ankle fusion procedures.

The panel voted 12-to-six in support of the safety of the product in the procedures and 10-to-eight in support of its efficacy. The advisors also voted 10-to-eight that Augment demonstrates a favourable benefit-to-risk profile for the same indication.

The FDA is not required to follow its advisory committees' advice, but it often does so. In this case, the agency's own briefing documents for the bone graft appeared to take a less positive stance on the product, sending the company's shares down by more than 30 per cent in spite of the close but positive panel vote.

The product is the first fully synthetic alternative to autograft being developed for use in orthopaedic surgery where the use of bone graft is indicated. It is designed to be placed directly into an open surgical site to stimulate bone regeneration.

The panel's vote was based on data from a randomised, controlled, non-inferiority study comparing Augment Bone Graft to autograft in which Augment Bone Graft was shown to be statistically non-inferior for the primary study endpoint (50 per cent osseous bridging on CT scans at six months).

If it is cleared for marketing by the agency, Augment Bone Graft would be "the first new recombinant protein technology for orthopaedics introduced to the market in nearly a decade and the first and only cost effective fully synthetic bone growth factor replacement for autograft with Level 1 data supporting its safety and efficacy," according to the company.

The company said it expects to launch Augment with 150 to 175 total independent sales representatives, an increase over its previous estimate of from 80 to 100 independent reps at launch. BioMimetic is also building its internal sales and marketing team. The company has already hired five new sales management employees and has plans to hire new sales reps as well.